MAUDE Adverse Event Report: INSET; INSET I 60/9 GREY LUER

Lot Number	5201397
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that she had several multiple infusion set issues including bent cannulas, poor patch adhesion and tubing disconnected from the site adhesion.The blood glucose level was 132mg/dl at the time of the report and she did not notice any damage when the package was first opened.No further information available.

• Brand Name: INSET
• Common Device Name: INSET I 60/9 GREY LUER
• MDR Report Key: 8530350
• Report Number: 3003442380-2019-01178
• Device Sequence Number: 1629260
• Product Code: FPA
• UDI-Device Identifier: 05705244016804
• UDI-Public: 05705244016804
• Combination Product (Y/N): N
• PMA/510(K) Number: K032854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 09/01/2020
• Device Lot Number: 5201397
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 04/19/2019
• Patient Sequence Number: 1